usfda

The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Vecuronium Bromide Injection in the strengths of 10mg and 20mg, Aurobindo Pharma said in a BSE filing.

Strides Vivimed Pte Ltd, Singapore, a 50:50 joint venture with Vivimed Labs, has received approval from the United States Food & Drug Administration (US FDA) for Albendazole tablets in the strength of 200 mg, Strides Pharma Science said in a BSE filing.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Olopatadine Hydrochloride ophthalmic solution USP, 0.1 percent, Alembic Pharmaceuticals said in a filing to BSE.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Candesartan Cilexetil tablets USP in the strengths of 4 mg, 8 mg, and 16 mg, Alembic Pharmaceuticals said in a filing to BSE.

The company's wholly owned subsidiary Orit Laboratories LLC has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Glycopyrrolate tablets USP in the strengths of 1 mg and 2mg, Alembic Pharmaceuticals said in a BSE filing.

The company has received final approval from the United States Food and Drug Administration (USFDA) to market Baclofen tablets in the strengths of 10 mg and 20 mg, Zydus Cadila said in a filing to BSE.

The Ahmedabad-based group has received final approval from the US Food and Drug Administration (USFDA) to market the drug in the strengths of 10 mg, 20 mg, 40 mg and 80 mg, Zydus Cadila said in a statement.

The company's abbreviated new drug application (ANDA) for Dimethyl Fumarate delayed release capsules in the strengths of 120 mg and 240 mg has been granted tentative approval by the United States Food and Drug Administration (USFDA), Shilpa Medicare said in a BSE filing.

Glenmark Pharmaceuticals, USA, has been granted final approval by the United States Food and Drug Administration (USFDA) for Teriflunomide tablets in the strengths of 7 mg and 14 mg, the company said in a BSE filing.

The product approved by the United States Food and Drug Administration (USFDA) is a generic version of AstraZeneca Pharmaceuticals LP's Pulmicort Respules Inhalation Suspension, 0.5 mg/2 mL, Lupin said in a regulatory filing.

Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/gram and 1 mg/gram, the company said in a BSE filing.

The company has received approval from the United States Food and Drug Administration (USFDA) to market its Doxercalciferol injection, 4 mcg/2 mL (2 mcg/mL) multi-dose vials, Lupin said in a statement.

The company said it had submitted a detailed compliance report to the US Food and Drug Administration (USFDA) within the stipulated period in response to the Form 483 containing eight observations issued to it by the regulator.

"Granules Pharmaceuticals Inc, a wholly-owned foreign subsidiary of the company located in Chantilly, Virginia, US has completed USFDA (US Food and Drug Administration) inspection from October 22-26, 2018 with two Form 483 observations," the company said in a BSE filing.